Attorneys general from four Democrat-led states have formally petitioned the Food and Drug Administration (FDA), urging the agency to remove what they describe as unnecessary mifepristone restrictions. This move on June 5th by New York, New Jersey, Massachusetts, and California aims to align regulations with the abortion pill’s established safety and efficacy, particularly following recent calls for a new safety review.
The Push for Fewer Hurdles on Abortion Pill Access
The petition urges the FDA to recognize mifepristone’s extensive safety record. This follows Health and Human Services Secretary Robert F. Kennedy Jr.’s announcement of a safety review, which an FDA spokesperson confirmed. Approved in 2000, the FDA describes mifepristone as a drug blocking progesterone, crucial for pregnancy, typically used with misoprostol for early termination.
Mifepristone’s Role and Post-Roe Landscape
Medication abortions, often using mifepristone, comprised 63% of U.S. abortions in 2023, a Guttmacher Institute report shows. Since Roe v. Wade’s overturn, Washington Post data indicates 17 states have banned it, and 10 others restrict it. California AG Rob Bonta highlighted its critical role for vulnerable populations, calling it a “lifeline.”
Challenging the REMS Program’s Necessity
The states’ petition specifically targets mifepristone’s Risk Evaluation and Mitigation Strategy (REMS). The FDA uses REMS to ensure a drug’s benefits outweigh risks, currently applied to 71 drugs. For mifepristone, this includes prescriber lists, patient consent forms, and pharmacy record-keeping. The attorneys general argue these REMS create “unnecessary and burdensome hurdles,” citing mifepristone’s decades of safe use by over 7.5 million U.S. women without new safety concerns.
Broader Support and an Alternative Plea to the FDA
This action aligns with broader efforts; seventeen other states and D.C. are suing the FDA in a separate case for looser mifepristone rules, Reuters reported. Leading medical groups also advocate for removing REMS. If REMS isn’t lifted, the petition asks the FDA to use “discretion not to enforce” some or all restrictions in the petitioning states, given their existing medical practice regulations.
The collective action by these states underscores a significant push to revise mifepristone restrictions, grounding them in scientific evidence of its safety and efficacy. Their petition challenges the FDA to reconsider regulations that, according to proponents of change, limit access to essential reproductive healthcare for millions across the United States.
